ISO/TS 22163:2017 鉄道アプリケーション—品質管理システム—鉄道組織のビジネス管理システム要件：ISO 9001：2015および鉄道セクターでのアプリケーションの特定要件 | ページ 6

3.1.1

application software

computer program that performs a set of functions to support the execution of a process

Note 1 to entry: This can be a software programme, database, computerized spreadsheet, electronic file or web tool, bought from the market or developed by the organization

3.1.2

availability

<item> ability to be in a state to perform as required

Note 1 to entry: Availability depends upon the combined characteristics of the reliability, recoverability, and maintainability of the item, and the maintenance support performance

[SOURCE: IEC 60050‑192:2015, 192-01-23]

3.1.3

commissioning

phase before handover to a customer, in which a product is final tested under operational conditions to verify it functions according to its specifications

Note 1 to entry: The product is then prepared to start operation.

3.1.4

component

sub-device above the integration level of the smallest replaceable unit of a system in service or maintenance

3.1.5

configuration audit

audit performed in accordance with documented procedures to determine whether a product conforms to its requirements and product configuration information

[SOURCE: ISO 10007:2003, 5.6]

3.1.6

configuration baseline

approved product configuration information that establishes the characteristics of a product at a point in time that serves as reference for activities throughout the life cycle of the product

[SOURCE: ISO 10007:2003, 3.4]

3.1.7

configuration status accounting

formalized recording and reporting of product configuration information, the status of proposed changes and the status of the implementation of approved changes

[SOURCE: ISO 10007:2003, 5.5]

3.1.8

consignment stock

stock owned by an external provider, but held by the organization to ensure availability of parts

3.1.9

critical

critically

objects having the potential of introducing high risks that can threaten quality, safety or business performance, based on a risk assessment

3.1.10

deferred work

activity which is part of a predetermined sequence in a process that is delayed or postponed

3.1.11

deliverables

all types of output for the scope of supply to fulfil set requirements

3.1.12

first article inspection

set of inspection and verification activities in order to validate a production process

3.1.13

Failure Reporting Analysis and Corrective Action System

FRACAS

closed loop process used to improve dependability of current and future designs by feedback of testing, modification and use experience

[SOURCE: IEC 60050‑192:2015, 192-12-04]

3.1.14

functional requirement

dedicated requirement or capability of a function within the functional breakdown structure

3.1.15

gate criteria

acceptance criteria for deliverables at gates in order to support the decisions to be taken, such as accepted, conditionally accepted or rejected

3.1.16

handover

acceptance criteria for deliverables at gates in order to support the decisions to be taken, such as accepted, conditionally accepted or rejected

3.1.17

installation

phase after delivery at customer premises and prior to commissioning

Note 1 to entry: Installation is a typical phase of infrastructure activities.

3.1.18

integration maturity

degree of fulfilment of the integration requirements of a productEXAMPLEAlready or never integrated in the organization’s products.

3.1.19

integration requirements

requirements regarding integration of a system into a parent system and its fulfilment of functional requirements in this environment

3.1.20

key performance indicator

KPI

indicator, selected by the top management, to evaluate the performance of the business management system

3.1.21

life cycle costing

LCC

process of economic analysis to assess the cost of an item over its life cycle or a portion thereof

[SOURCE: IEC 60050‑192:2015, 192-11-11]

3.1.22

maintainability

<item> ability to be retained in, or restored to a state to perform as required, under given conditions of use and maintenance

Note 1 to entry: Given conditions would include aspects that affect maintainability, such as: location for maintenance, accessibility, maintenance procedures and maintenance resources.

[SOURCE: IEC 60050‑192:2015, 192-01-27]

3.1.23

maintenance

combination of all technical and management actions intended to retain an item in, or restore it to a state in which it can perform as required

Note 1 to entry: Management is assumed to include supervision activities.

[SOURCE: IEC 60050‑192:2015, 192-06-01]

3.1.24

manufacturing

activities to realize products including overhaul and repair

Note 1 to entry: of an organizations value chain.

3.1.25

multidisciplinary approach

way of working involving different functions in one team on a specific subjectEXAMPLEEngineering, safety and procurement.

3.1.26

non-functional requirements

frame conditions under which functional requirements are met

3.1.27

operational maturity

degree of fulfilment of the functional requirements of a product or serviceEXAMPLENot existing, under development, ready to use

3.1.28

product configuration information

requirements for product design, realization, verification, operation and support

[SOURCE: ISO 10007:2003, 3.9]

3.1.29

product life cycle

time of the entire life cycle of a product from inception, through design and manufacture, to service and disposal

3.1.30

product equipment

equipment used for productionEXAMPLEMachineries, tools, jigs, fixtures, templates, textures, test benches, software production tools.

Note 1 to entry: Handcraft equipment (e.g. hammer, screwdrivers) is not considered as production equipment.

3.1.31

project core team

people from different functions appointed to support the project manager in leading and controlling the project

3.1.32

project management

planning, organizing, monitoring, controlling and reporting of all aspects of a project, and the motivation of all those involved in it to achieve the project objectives

[SOURCE: ISO 10006:2003, 3.6]

3.1.33

quality assurance methods

methods applied to qualify, verify or validate the implementation of requirements in order to focus on error prevention rather than detection

Note 1 to entry: Quality assurance methods can be FMEA, FMECA, quality function deployment, etc.

3.1.34

quality deficiency cost

QDC

additional costs resulting from nonconforming products, processes or equipment

Note 1 to entry: QDC can be distinguished by causer (e. g. sales, engineering, production, purchasing, project management) and on phase of occurrence (e. g. tender, design, production, post-delivery)

Note 3 to entry: QDC can also be called nonconformity costs

3.1.35

reliability

probability of performing as required for the time interval (t1, t2), under given conditions

Note 1 to entry: Given conditions include aspects that affect reliability, such as: mode of operation, stress levels, environmental conditions, and maintenance, where applicable.

Note 2 to entry: It is usually assumed that the item is in a state to perform as required at the beginning of the time interval.

[SOURCE: IEC 60050‑192:2015, 192-05-05]

3.1.36

safety

<product safety> freedom from unacceptable risk of harm

[SOURCE: IEC 62278, 3.35]

3.1.37

safety case

documented demonstration that the product complies with the specified safety requirements

[SOURCE: IEC 62278:2002, 3.36]

3.1.38

safety integrity level

SIL

one of a number of defined discrete levels for specifying the safety integrity requirements of the safety functions to be allocated to the safety related systems

[SOURCE: IEC 62278:2002, 3.38]

3.1.39

safety-related

carries responsibility for safety

[SOURCE: IEC 62425:2007, 3.1.54]

3.1.40

site

organization, having activities in design and development and (or) manufacturing and (or) maintenance (fleet maintenance, refurbishment and component overhaul and (or) repairs) in defined scopes placed in a single location

3.1.41

supply chain

system of organizations, people, activities, information and resources involved in transforming materials and knowledge in a product or a service for the customer

3.1.42

transfer

complete or partial handover of process ownership for tasks or activities from internal product realization to an internal entity